A Phase Ib/II Clinical Study on AK112 Combined or Not Combined With AK119 in pMMR/MSS Colorectal Cancer

Sponsor
Akeso
Study ID
NCT05846867
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AK119 — DRUG
    AK119 IV every 2 weeks.intravenous infusion
  • AK112 — DRUG
    AK112 IV every 2 weeks.intravenous infusion
  • Oxaliplatin — DRUG
    Oxaliplatin: 85mg/m2, intravenous infusion
  • Irinotecan — DRUG
    Irinotecan 180mg/m2, intravenous infusion
  • Calcium folinate — DRUG
    Calcium folinate: 400mg/m2, intravenous infusion
  • Fluorouracil — DRUG
    Fluorouracil 400mg/m2, intravenous injection

Study Details

This is an open label, multicenter Phase Ib/II clinical study on the efficacy and safety of AK119 and AK112 in combination with or without chemotherapy, and AK112 monotherapy in pMMR/MSS CRC

Key Dates

Start date
May 8, 2023
Status verified
Mar 2026
Primary completion
May 8, 2026
Completion
Aug 11, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AK119 20mg/kg+ AK112 20mg/kg
    Subjects will receive AK119 plus AK112 via intravenously (IV) Q2W, up to 2 years
  • Experimental: AK119 40mg/kg+ AK112 20mg/kg
    Subjects will receive AK119 plus AK112 via intravenously (IV) Q2W, up to 2 years
  • Experimental: AK119 + AK112 20mg/kg +mFOLFOX6
    Subjects will receive AK119 and AK112 plus mFOLFOX6 via intravenously (IV)Q2W, up to 12 cycles. Afterward, AK119 and AK112 will continue to be treated up to 2 years.
  • Experimental: AK119 + AK112 20mg/kg +FOLFIRI
    Subjects will receive AK119 and AK112 plus FOLFIRI via intravenously (IV)Q2W, up to 12 cycles. Afterward, AK119 and AK112 will continue to be treated up to 2 years.
  • Experimental: AK112 20mg/kg
    Subjects will receive AK112 via intravenously (IV) Q2W, up to 2 years

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 2 years ]

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